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MIGRAINE IN PRIMARY CARE ADVISORS
Vienna, 25 October 2002, 2-6 pm
Individualising migraine care:
The clinical relevance of providing different
modes of administration of antimigraine
drugs
Introduction and objectives
Dr Andrew Dowson
Kings’ Headache Service, London
Programme
• Dr Andrew Dowson: Introduction and
objectives
• Dr Trevor Rees: Modes of administration of
available antimigraine drugs: a review of
their strengths and weaknesses
• Dr Bruce Charlesworth: The clinical profile of
the conventional tablet, orally dispersible
tablet and nasal spray formulations of
zolmitriptan (Zomig®)
• Break
Programme
What factors should be considered in the
choice of formulation to be used for
antimigraine therapies?
• Dr Andrew Dowson: Selection of initial
therapy
• Dr Sue Lipscombe: Follow-up care:
monitoring treatment and selection of
therapy
• General discussion
Objectives of today’s meeting
• Review available formulations of
antimigraine drugs
– Emphasis on the triptans
• Review the clinical profile of the Zomig
formulations
• Agree on concepts of individualisation
of care for migraine
Objectives of today’s meeting
• Review the factors that should be
evaluated in choosing the appropriate
formulation for each patient
• Develop recommendations for the
prescription of different triptan
formulations in primary care
Outputs from the project
•
•
•
Article to be published in a learned
journal
MIPCA newsletter (‘popular’ GP
version)
Slide set for educational purposes
Modes of administration of available
antimigraine drugs: a review of their strengths
and weaknesses
Dr Trevor Rees
Hawthorns Surgery, Sutton Coldfield
Overview
• Available drugs and formulations in the
UK
• Review of clinical profile of different
triptan formulations
– Relative strengths and weaknesses
Available drugs and formulations in
the UK
OTC acute medications
• Simple analgesics/NSAIDs and
combination medications (e.g.
Solpadeine)
– Conventional tablets
– Dispersible tablets
Available drugs and formulations
in the UK
Prescribed acute medications
• NSAIDs
– Conventional tablets
• Analgesic-anti-emetic combinations
– Tablets / dispersible tablets
• Analgesic-isometheptene combinations
(Midrid)
– Capsules
• Analgesic-codeine combinations (Migraleve)
– Tablets
Available drugs and formulations
in the UK
Prescribed acute medications
• Triptans
– Conventional tablets (all)
– Orally dispersible tablets (Zomig, Maxalt)
– Nasal sprays (Imigran, Zomig)
– Subcutaneous injection (Imigran)
• Ergotamine
– Conventional tablets (Cafergot / Migril)
Available drugs and formulations
in the UK
Prescribed prophylactic medications
• Beta-blockers
– Conventional tablets, sustained-release
capsules, oral solutions
• Serotonin antagonists
• Anticonvulsants
• Antidepressants
– All conventional tablets
Clinical profiles of the different
triptan formulations
Conventional tablets
• Generally well absorbed from the intestine
• Effective therapy
– 60% of patients with headache relief after 2
hours
• Onset of action within 30-60 min
• Generally well tolerated
• Differences between the triptans are
generally small and of uncertain clinical
significance
Sheftell FD, Fox AW. Cephalalgia 2000;20(Suppl2):14-24
Dowson AJ, Cady RK. Rapid Reference to Migraine, 2002
Conventional tablets: Efficacy
Proportion of patients with headache relief after 2 hours
(maximum published values)
90
80
Patients (%)
70
60
50
40
30
20
10
0
Sum
100
Sum
50
Nara
2.5
Zolm Riz 10
2.5
Almo
12.5
Ele 40
Dowson AJ, Cady RK. Rapid Reference to Migraine, 2002
Orally dispersible tablets
• Generally well absorbed from the
intestine
• Effective therapy
– 60% of patients with headache relief after
2 hours
• Onset of action within 30-60 min
• Generally well tolerated
• Similar clinical profile to conventional
tablet formulations
Sheftell FD, Fox AW. Cephalalgia 2000;20(Suppl2):14-24
Dowson AJ et al. Cephalalgia 2001;21:419-20
ODT tablets: Efficacy
Proportion of patients with headache relief after 2 hours
(maximum published values)
90
80
Patients (%)
70
60
50
Tablet
ODT
40
30
20
10
0
Zolmitriptan
Rizatriptan
Sheftell FD, Fox AW. Cephalalgia 2000;20(Suppl2):14-24
Dowson AJ et al. Cephalalgia 2001;21:419-20
Nasal sprays
• Well absorbed from the nasal mucosa, but
some also absorbed from the intestine
• Effective therapy
– Up to 70% of patients with headache relief after 2
hours
• Rapid onset of action: within 15 min
• Generally well tolerated, with some reports of
taste disturbances
• May have superior clinical profile to oral
formulations
Sheftell FD, Fox AW. Cephalalgia 2000;20(Suppl2):14-24
Purdy A et al. Cephalalgia 2001;21:418-9
Nasal sprays: Efficacy
Proportion of patients with headache relief after 2 hours
(maximum published values)
80
70
Patients (%)
60
50
40
Nasal spray
Oral
30
20
10
0
Zolmitriptan
Sumatriptan
Sheftell FD, Fox AW. Cephalalgia 2000;20(Suppl2):14-24
Purdy A et al. Cephalalgia 2001;21:418-9
Sumatriptan subcutaneous
injections
• Very rapid absorption
• Most effective therapy
– >80% of patients with headache relief after 2
hours
• Very rapid onset of action: within 10 min
• Has superior efficacy profile to all other
formulations
• Has more associated side effects than all
other formulations
Sheftell FD, Fox AW. Cephalalgia 2000;20(Suppl2):14-24
Subcutaneous sumatriptan: Efficacy
Proportion of patients with headache relief after 2 hours
(maximum published values)
90
80
Patients (%)
70
60
50
40
30
20
10
0
Subcut 6 mg
Nasal spray 20
mg
Oral 100 mg
Sheftell FD, Fox AW. Cephalalgia 2000;20(Suppl2):14-24
Strengths and weaknesses of
different triptan formulations
Conventional tablets
Strengths
• Familiarity/comfort
• Most drugs well
absorbed from intestine
• Clinical studies show
that triptan tablets
provide effective
migraine relief
• Well tolerated
• Relative cost
Weaknesses
• Need water for use
• Gastric stasis
associated with
migraine
• May not be effective for
some patients/ attacks
• Slower onset of action
(30-60 min)
Orally dispersible tablets (ODT)
Strengths
• Innovative migraine
treatment
• Flexible use: No need
for water
• Generally well absorbed
from intestine
• Clinical studies show
that ODT triptans are
effective for migraine
• As well tolerated as
conventional tablets
• Relative cost
Weaknesses
• Not familiar
• Gastric stasis
associated with
migraine
• May be no more
effective than
conventional tablets
• May not be effective for
some patients/ attacks
• Slower onset of action
• Not absorbed from
mouth
Nasal sprays
Strengths
• Innovative migraine
treatment
• Flexible use: No need
for water
• Good nasal absorption
• Rapid onset of action
(15 min)
• May be more effective
than tablet formulations
• As well tolerated as
conventional tablets
Weaknesses
• Not familiar
• Some absorption may
occur in the stomach
• May not be effective for
some patients/ attacks
• Some reports of taste
disturbances
Subcutaneous injection
Strengths
• Innovative migraine
treatment
• Flexible use: No need
for water
• Fastest onset of action
(10 min)
• More effective than all
other formulations
• Non-needle injectors on
horizon
Weaknesses
• Fear of injections
• More side effects than
with other formulations
• Some side effects may
be disturbing to the
patient and restrict use
• Relative expense
Conclusions
• All triptan drugs and formulations are
effective and well tolerated acute treatments
for migraine
• Triptans are the ‘gold standard’ treatment
• Different triptan formulations have their own
strengths and weaknesses
• The choice of triptan formulation may not be
obvious from the outset
• Guidance to help the physician choose an
appropriate formulation for each patient
would be welcome
What factors should be considered in the
choice of formulation to be used for
antimigraine therapies?
Selection of initial therapy
Dr Andrew Dowson
Kings’ Headache Service, London
New MIPCA guidelines for
migraine management
Individualising care processes:
Initial consultation and
treatment
Copyright MIPCA 2002, all rights reserved
Detailed history, patient education and buy-in
Diagnostic screening and differential diagnosis
Assess illness severity
Attack frequency and duration
Pain severity
Impact (MIDAS or HIT questionnaires)
Non-headache symptoms
Patient history and preferences
Intermittent
mild-to-moderate migraine
(+/- aura)
Intermittent
moderate-to severe migraine
(+/- aura)
Behavioural/complementary therapies
Aspirin/NSAID (large dose)
Aspirin/paracetamol plus anti-emetic
Initial consultation
Rescue
Initial treatment
Oral triptan
Rescue
Nasal spray/subcutaneous
triptan
Dowson AJ et al. Curr Med Res Opin 2002;18: in press.
Copyright MIPCA 2002, all rights reserved
Detailed history, patient education and buy-in
Diagnostic screening and differential diagnosis
Assess illness severity
Attack frequency and duration
Pain severity
Impact (MIDAS or HIT questionnaires)
Non-headache symptoms
Patient history and preferences
Intermittent
mild-to-moderate migraine
(+/- aura)
Intermittent
moderate-to severe migraine
(+/- aura)
Behavioural/complementary therapies
Aspirin/NSAID (large dose)
Aspirin/paracetamol plus anti-emetic
Initial consultation
Rescue
Initial treatment
Oral triptan
Rescue
Nasal spray/subcutaneous
triptan
Dowson AJ et al. Curr Med Res Opin 2002;18: in press.
Assess illness severity
• Attack frequency and duration
• Pain severity
• Impact on daily living
– MIDAS/HIT questionnaires
• Non-headache symptoms
• Patient factors
– History, preference and other illnesses
Matchar DB et al. Neurology 2000; www.aan.com.
Bedell AW et al. Primary Care Network 2000.
Assessment of severity
Mild-to-moderate migraine Moderate-to-severe
migraine
Headaches mild-tomoderate in intensity
Headaches moderate or
severe in intensity
Non-headache symptoms
not severe in intensity
Significant non-headache
symptoms, possibly
severe
Impact not significant:
MIDAS Grade I or II
HIT Grade 1 or 2
Significant impact:
MIDAS Grade III or IV
HIT Grade 3 or 4
Matchar DB et al. Neurology 2000; www.aan.com.
Bedell AW et al. Primary Care Network 2000.
Selection of initial therapy
•
•
•
•
Evidence-based medicine (Duke database)
suggests:
Behavioural therapy recommended for all
Acute therapy recommended for all
Prophylactic therapy recommended for
certain patients
Complementary therapies may be useful as
adjunctive therapy
Headache Consortium. Neurology 2000; www.aan.com.
Bedell AW et al. Primary Care Network 2000.
Goals of therapy
• Acute medications: to rapidly relieve
the headache and other symptoms, and
permit the return to normal activities
(within 2 hours?)
• Prophylactic medications: to reduce
headache frequency by >50%
Matchar DB et al. Neurology 2000; www.aan.com.
Bedell AW et al. Primary Care Network 2000.
Ramadan NM etal. Neurology 2000; www.aan.com.
Strategy for providing initial acute therapy
in individualised care
Migraine
diagnosis
Severity
assessment
Stratified care
Migraine attack
Mild to moderate migraine
Moderate to severe migraine
Initial therapy
Initial therapy
If unsuccessful
Rescue
Rescue
Staged care
Dowson AJ et al. Curr Med Res Opin 2002;18: in press
Recommended initial acute
treatments
Mild-to-moderate migraine
• Aspirin or NSAIDs (high doses)
• Aspirin/paracetamol plus anti-emetics
• Paracetamol plus isometheptene
– Use if possible before headache starts
• Rescue medications
– Oral triptans
– Use for any headache severity
Matchar DB et al. Neurology 2000; www.aan.com.
Recommended initial acute
treatments
Moderate-to-severe migraine
• Oral triptans (tablet/ODT)
– Use after the headache starts, if possible
when it is mild in intensity
• Rescue medications
– Nasal spray or subcutaneous triptans
– Symptom control
Matchar DB et al. Neurology 2000; www.aan.com.
Who should receive a triptan as
initial therapy?
• Patients with moderate-to-severe
migraine
• Patients with any severity migraine who
have failed on other acute medications
Matchar DB et al. Neurology 2000; www.aan.com.
What formulation of triptan should
be used as initial therapy?
• Is a conventional tablet always the best
choice?
• Would ODT formulations be more
appropriate?
• Should any patients receive nasal
spray or subcutaneous formulations
from the outset?
Circumstances where ODT or non-oral
formulations may be appropriate
• ODT / nasal
– Unpredictable attacks
– Need for greater convenience
– Patient preference
• Nasal / subcutaneous
–
–
–
–
–
Severe / fast onset attacks
Need for rapid response
Severe nausea
Vomiting
Patient preference
Dowson AJ et al. Curr Med Res Opin 2002;18: in press
What formulation of triptan should
be used as rescue therapy?
•
•
•
•
•
Second dose of initial medication?
Alternative oral triptan?
ODT formulation?
Nasal spray?
Subcutaneous injection?
Factors affecting the choice of rescue
medication
•
•
•
•
•
•
Impact
Work / lifestyle pressures
Severity of attack
Length of attack
Vomiting / severe nausea
Patient preference
Patient preference factors: What do
patients experience?
•
•
•
•
•
Headache relief too slow
Inadequate overall relief
Inconsistency of response
Headache returns after initial relief
Too many side effects
Lipton RB, Stewart WF. Headache 1999;39(Suppl2):20-6
What do patients want? How do they
express their preferences?
•
•
•
•
•
•
Greater speed of action
Enhanced overall effectiveness
Restored ability to function
Fewer side effects
Satisfaction with therapy
Greater convenience
Dowson AJ, manuscript in preparation
Strategy for providing prophylactic
medications in individualised care
• Prophylactic medications should be
provided:
– For patients with frequent, high-impact migraine
attacks (4/month?)
– Where acute medications are ineffective or
precluded by safety concerns
– For patients who overuse acute medications
and/or have CDH
– For patients with the rare migraine variants
• However: acute medications should also be
provided for breakthrough attacks
Ramadan NM et al. Neurology 2000; www.aan.com.
Bedell AW et al. Primary Care Network 2000.
Dowson AJ et al. MIPCA 2000.
Recommended initial prophylactic
treatments
• First-line medications:
– Beta-blockers (propranolol, metoprolol,
timolol, nadolol)
– Anticonvulsants* (sodium valproate)
– Antidepressants* (amitriptyline)
• Second-line medications
– Serotonin antagonists (pizotifen,
methysergide, cyproheptadine)
* Not licensed for migraine in the UK
Ramadan NM et al. Neurology 2000; www.aan.com.
Factors influencing the choice of
initial prophylactic medication
• Side effects mean that certain patients are
not able to take specific drugs
– Beta-blockers may not be suitable for
sportspeople
• Weight gain experienced with many drugs
may limit compliance in a largely female
population
• Anticonvulsants and antidepressants may be
used for patients with concurrent conditions
• Anticonvulsants and antidepressants are
also effective if CDH is suspected
Conclusions
• The choice of initial drug can be
individualised for each patient’s needs
• Oral triptans are suitable acute
medications for most patients
• ODT, nasal spray and subcutaneous
triptans are suitable initial medications
for certain patients and/or as rescue
medication
Follow-up care: monitoring treatment and
selection of therapy
Dr Sue Lipscombe
Park Crescent New Surgery, Brighton
New MIPCA guidelines for
migraine management
Follow-up treatment
Copyright MIPCA 2002, all rights reserved
Oral triptan
Aspirin/NSAID (large dose)
Aspirin/paracetamol plus anti-emetic
If unsuccessful
Rescue
Oral triptan
Initial
Initial
treatment
treatment
Follow-up treatment
Alternative oral triptan
Nasal spray/subcutaneous
triptan
If unsuccessful
Frequent headache
(i.e. 4 attacks per month)
Migraine
Consider prophylaxis +
acute treatment for
breakthrough migraine
attacks
If unsuccessful
Chronic daily
Headache (CDH)?
If
management
unsuccessful
Consider referral
Dowson AJ et al. Curr Med Res Opin 2002;18: in press.
Copyright MIPCA 2002, all rights reserved
Oral triptan
Aspirin/NSAID (large dose)
Aspirin/paracetamol plus anti-emetic
If unsuccessful
Rescue
Oral triptan
Initial treatment
Follow-up treatment
Alternative oral triptan
Nasal spray/subcutaneous
triptan
If unsuccessful
Frequent headache
(i.e. 4 attacks per month)
Migraine
Consider prophylaxis +
acute treatment for
breakthrough migraine
attacks
If unsuccessful
Chronic daily
Headache (CDH)?
If
management
unsuccessful
Consider referral
Dowson AJ et al. Curr Med Res Opin 2002;18: in press.
Recommended follow-up
procedures
• Instigate proactive long-term follow-up
procedures
• Monitor the outcome of therapy
– Headache diaries
– Impact questionnaires (MIDAS/HIT)
• Make appropriate treatment decisions
Dowson AJ et al. Curr Med Res Opin 2002;18: in press
Who are the diaries for?
• The patient
• The doctor
• Both
What is the diary for?
• Recording data
– Triggers, patterns, results of medication,
frequency of medication taken
• To make the patient feel the doctor is
interested
• To help the doctor make lifestyle and
medication suggestions
Headache diaries
• Beneficial for the prospective management
of migraine
• Two types of diary can be used
– Patient-held long-term diary for continual use,
containing basic information on patterns of
headache
– Short-term diary used over a specific timescale
for intense monitoring
• The two diaries can be used in tandem
• Data from the diaries can be used to
individualise follow-up treatment decisions
Follow-up treatment decisions
• Acute medications
– Patients effectively treated should
continue with the original therapy
• Analgesic-based medications
• Triptans
– Patients who fail on original therapy
should be offered other therapies, based
on clinical issues and patient preference
• Analgesic-based medications  oral triptan
• Triptan  alternative triptan
Dowson AJ, Cady RC. Rapid Reference to Migraine 2002.
Individual treatment for individual
attacks
• Doctor and patients may be able to
identify different severities and types of
attacks
• The patient may choose to have a
range of treatments to hand to treat
each attack with the medication they
feel most appropriate
• If this is the case, then several
prescriptions may be necessary
Switching between triptans
• If one oral triptan fails, an alternative
oral triptan may be effective
– ODT triptan may be suitable for patients
who cannot predict their attacks easily
and/or require greater convenience of use
• Patients needing rapid onset of action
and greater convenience of use may
benefit from nasal spray and injection
formulations
Switching between triptans
• Patients needing greater overall relief
and/or experiencing significant impact
may benefit from nasal spray or
subcutaneous formulations
• Patients reporting bothersome side
effects may require a triptan with a
better tolerability profile
• ODT, nasal spray and subcutaneous
formulations may also be suitable as
rescue medications
Follow-up treatment decisions
• Prophylactic medications
– Initial dose can be titrated up as necessary
to achieve an effective dose
– Medication needs to be provided for an
adequate time period (up to 3 months)
– If effective, treatment can continue for 6
months, after which it may be stopped
– If ineffective, another prophylactic
medication may be tried
– Monitor closely for side effects and
patients’ subjective impressions
Dowson AJ et al. Curr Med Res Opn 2002;18: in press
Follow-up treatment decisions
• Specialist referral
– Migraine patients refractory to repeated
acute and prophylactic medications
– Patients who have developed CDH during
treatment
– Patients suspected of having sinister
headaches, rare migraine variants, cluster
headache and other refractory nonmigraine headaches
– Patient request
Specialist referrals
• Worrying migraine – are they TIAs or
hemiplegic migraine?
• Worrying times – pregnancy, breast
feeding, menopause
• For specialist treatment only, e.g.
methysergide, botox, off-licence drugs.
• For special investigations – CT, MRI
Conclusions
• Follow-up should be available for migraine
patients
– Headache diaries
– Impact questionnaires
• Acute and prophylactic medications can be
changed to maximise therapeutic effect and
patient satisfaction
• The different triptan formulations provide
flexible therapy that can be targeted to each
patient’s needs and desires